Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II

Completed

Conditions studied: Cachexia

In brief

The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy. Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (\> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.

Key facts

Study ID

NCT01694602

Run by

The University of Texas Medical Branch, Galveston

People needed

8

Starts

2012-11-01

Expected to finish

2015-06-01

Last updated by the study team

2015-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (1) histological or cytological evidence of NSCLC without curative options;
• (2) over 18 years of age;
• (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
• (4) life expectancy of greater than 6 months based on the judgement of treating physician;
• (5) serum creatinine ≤1.5 times the upper limit of normal; and
• (6) willing and able to give informed consent.

You may not qualify if…

• 1) malabsorption, intractable vomiting or gastrointestinal obstruction
• 2) congestive heart failure
• 3) edema or ascites
• 4) liver function test results that will preclude administration of prescribed therapy
• 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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